Status:
ACTIVE_NOT_RECRUITING
Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Primary Dysmenorrhea
Eligibility:
FEMALE
13-19 years
Phase:
NA
Brief Summary
The study will use primary dysmenorrhea (PD; menstrual pain without an identified organic cause) as a model to examine biomarkers associated with menstrual and non-menstrual bodily pain in adolescent ...
Eligibility Criteria
Inclusion
- Female aged 13-19 years
- Self-reported menstrual cycle averaging 22-35 days
- Regular menstrual cycles for at least 6 months
- Access to a smartphone or email
- Right handed
- Body Mass Index (BMI) of 35 or less
- Able to read and understand English
- Ability and willingness to provide written informed assent/consent
- Availability of a parent to provide written parental permission (for participants under age 18)
Exclusion
- Use of oral contraceptives or any exogenous hormones in the previous 3 months prior to participation
- Presence of factors indicative of secondary dysmenorrhea (e.g., self-reported presence of persistent pelvic pain throughout the month)
- Diagnosis of chronic pain condition (e.g., Irritable bowel syndrome (IBS), functional abdominal pain, interstitial cystitis/painful bladder syndrome)
- Current self-reported severe depression, bipolar disorder, panic disorder, or ADHD, or current treatment for these conditions
- Diagnosis of an eating disorder within the last 6 months
- Current or past diagnosis of any psychotic disorder
- Currently pregnant
- Self-reported weekly use of alcohol, cannabis, and/or other illegal substances
- Use of stimulants (including methamphetamine and/or medications for the treatment of ADHD) or opioids in the previous 3 months. Participants who use other analgesics will be included but will be requested to not take these analgesics within the previous 24 hours of the laboratory session
- History of pelvic inflammatory disease or sexually transmitted disease
- Acute illness or injury that would potentially impact pain task performance (e.g., fever, flu symptoms) or that affect sensitivity of the extremities (e.g., Reynaud's disease). Potential participants who are being treated for cardiovascular disease(s) will be included pending discussion with the participant's primary physician
- Developmental delay, diagnosis of autism, or significant cognitive impairment that may preclude understanding of study procedures
- Presence of certain ferromagnetic appliance or implants (braces, retainers, spacers, wires, screws, etc.) in the mouth or any other body part that may be a contraindication for the magnetic resonance imaging (MRI) scanner
- Significant fear of enclosed places (claustrophobia)
Key Trial Info
Start Date :
December 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT04685343
Start Date
December 14 2020
End Date
December 1 2025
Last Update
November 19 2025
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478